FDA.reportPublic FDA data

PMA P050042S044

Device
ARCHITECT Anti-HCV, Alinity i Anti-HCV
Applicant
Abbott Laboratories, Inc.
PMA number
P050042
Supplement
S044
Product code
MZO
Decision date
2020-08-28
Generic name
Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement
Modifications to the sourcing and testing of materials used in the manufacture of an internal reference panel, which is used for quality control evaluation during in-process reagent manufacturing.

Current openFDA PMA Record#

Device
ARCHITECT Anti-HCV, Alinity i Anti-HCV
Applicant
Abbott Laboratories, Inc.
PMA number
P050042
Supplement
S044
Product code
MZO
Generic name
Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date
2020-08-28
Decision code
OK30
Date received
2020-07-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modifications to the sourcing and testing of materials used in the manufacture of an internal reference panel, which is used for quality control evaluation during in-process reagent manufacturing.